Positive data from Phase III study of Xgeva (Amgen) in Breast Cancer patients

Treatment with Xgeva (denosumab), from Amgen, resulted in a greater reduction in skeletal-related events in patients with Breast Cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a Phase III study published in Clinical Cancer Research. The study randomly assigned 2,046 patients to receive subcutaneous denosumab and intravenous placebo, or intravenous zoledronic acid and subcutaneous placebo. The data indicated that only 31 percent of patients on denosumab experienced a skeletal-related event compared with 36 percent assigned to zoledronic acid. Treatment with denosumab reduced the need for radiation therapy to the bone by 26 percent, and those patients also had an 18 percent lower risk for developing a skeletal-related event or hypercalcemia of malignancy. Quality of life also improved.

"Our data indicate that denosumab should be the treatment of choice for the prevention of skeletal-related events and hypercalcemia in patients with breast cancer that has metastasized to the bone," said Miguel Martin, M.D., Ph.D., professor of medicine and head of the Medical Oncology Service at Hospital General Universitario Gregorio Mara��n in Madrid, Spain. See: "Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid." Miguel Martin et al. Clin Cancer Res August 14, 2012; doi:10.1158/1078-0432.CCR-11-3310